Curio Digital Therapeutics has recently received 510(k) clearance from the US Food and Drug Administration (FDA) for its groundbreaking prescription digital therapeutic device, MamaLift Plus. This innovative device is designed to provide symptomatic relief for postpartum depression (PPD) in patients aged 22 years and older when used in conjunction with clinician-managed outpatient care.
The FDA’s approval of MamaLift Plus marks a significant milestone in the treatment of PPD, offering a new avenue for patients to manage this challenging condition. The device is intended to be administered over an eight-week period and has shown promising results in the treatment of mild to moderate PPD.
The approval of MamaLift Plus was supported by data from the Supporting Maternal Mental Health and Emotional Regulation (SuMMER) trial (NCT05958095). This pivotal study enrolled 141 patients who had recently given birth and were diagnosed with PPD. The trial successfully met its primary endpoint, demonstrating an improvement of four or more points on the Edinburgh Postnatal Depression Scale (EPDS) score.
Notably, 86.3% of patients in the MamaLift Plus arm experienced a clinically meaningful improvement in their symptoms, compared to only 23.9% of patients in the placebo arm. This underscores the efficacy of the digital therapeutic in addressing the complex challenges of PPD.
MamaLift Plus offers a range of digital therapies, including Cognitive Behavioural Therapy (CBT), Behavioural Activation Therapy (BAT), Interpersonal Therapy (IPT), and Dialectical Behaviour Therapy (DBT). These evidence-based therapies are delivered through the patient’s smartphone or tablet, providing a convenient and accessible means of treatment.
The approval of MamaLift Plus represents a significant advancement in the field of digital therapeutics for mental health conditions. By harnessing the power of technology, Curio Digital Therapeutics is paving the way for innovative solutions to support patients with postpartum depression and improve their quality of life.
